Dietary Intervention With Phytochemicals and Polyunsaturated Fatty Acids in Prostate Cancer Patients
NCT ID: NCT00433797
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
86 participants
INTERVENTIONAL
2007-06-30
2013-12-31
Brief Summary
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Detailed Description
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The intervention groups includes; control group, tomato group and multi-diet group. The intervention period is three week and will be completed before prostatectomy or radiation therapy.
Biomarkers og inflammation includes: acute phase proteins, cytokines, chemokines and other inflammatory mediators. Biomarker of antioxidant status includes vitamin C, vitamin E, glutathione, carotenoids, total antioxidant capacity and total phenolics. Oxidative stress markers includes; malondialdehyde, isoprostanes, 8-hydroxy-deoxyguanosine, oxidized vitamin C, total lipidperoxides (d-ROM) and protein carbonyls.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Tomato
Prostate cancer, phytochemical and PUFA
Patients with localized prostate cancer are supplemented with either tomato or a multi-diet cinsisting of grape juice, pomegranate juice, tomato, green tea, black tea, soy, selenium and PUFAs for 3 weeks.
2
Multi-diet
Prostate cancer, phytochemical and PUFA
Patients with localized prostate cancer are supplemented with either tomato or a multi-diet cinsisting of grape juice, pomegranate juice, tomato, green tea, black tea, soy, selenium and PUFAs for 3 weeks.
3
Control
Prostate cancer, phytochemical and PUFA
Patients with localized prostate cancer are supplemented with either tomato or a multi-diet cinsisting of grape juice, pomegranate juice, tomato, green tea, black tea, soy, selenium and PUFAs for 3 weeks.
Interventions
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Prostate cancer, phytochemical and PUFA
Patients with localized prostate cancer are supplemented with either tomato or a multi-diet cinsisting of grape juice, pomegranate juice, tomato, green tea, black tea, soy, selenium and PUFAs for 3 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* pN0/NXM0 (TNM/UICC 2002) and at least one negative prognosis factor for HDR-BT or low risk profile with the use of radical prostatectomy.
* Serum PSA\< 20 ng/mL, and Gleason score =\>6 or T1c- T3a, prostate volume \< 60mL
* Performance status 0-1
* Normal WBC and thromocytes, Hb \>11g/dl
Exclusion Criteria
* Life expectancy \> 5 år
* No possible co-morbidity (CVD, COPD, diabetes type I, vasculatory syndromes or inflammatory diseases that may affect quality of life and radiation therapy)
* Urinary retention, incontinens or IPPS score \<12
MALE
No
Sponsors
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Oslo University Hospital
OTHER
Norwegian Cancer Society
OTHER
The Research Council of Norway
OTHER
University of Oslo
OTHER
Responsible Party
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Rune Blomhoff
Professor
Principal Investigators
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Wolfgang Lilleby, MD
Role: PRINCIPAL_INVESTIGATOR
Rikshospitalet-Radiumhospitalet, Oslo
Sigbjørn Smeland, MD, PhD.
Role: PRINCIPAL_INVESTIGATOR
Rikshospitalet-Radiumhospitalet, Oslo
Locations
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Oslo Universuty Hospital, Radiumhospitalet and Aker
Oslo, , Norway
Countries
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References
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Paur I, Lilleby W, Bohn SK, Hulander E, Klein W, Vlatkovic L, Axcrona K, Bolstad N, Bjoro T, Laake P, Tasken KA, Svindland A, Eri LM, Brennhovd B, Carlsen MH, Fossa SD, Smeland SS, Karlsen AS, Blomhoff R. Tomato-based randomized controlled trial in prostate cancer patients: Effect on PSA. Clin Nutr. 2017 Jun;36(3):672-679. doi: 10.1016/j.clnu.2016.06.014. Epub 2016 Jun 30.
Other Identifiers
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S-06187 (REK Sør)
Identifier Type: OTHER
Identifier Source: secondary_id
2006-18 (RRHF)
Identifier Type: OTHER
Identifier Source: secondary_id
PFPI
Identifier Type: -
Identifier Source: org_study_id